Computerized oral prescription administration devices and associated systems and methods

ABSTRACT

Computerized oral prescription administration (COPA) devices, systems, and methods are provided. In one embodiment, a method of assembling a substance dispensing device includes forming a mouthpiece including a recess customized to match with an intended user&#39;s unique dentition; coupling a sensing element to the recess of the mouthpiece, the sensing element configured to determine if the intended user&#39;s unique dentition is positioned within the recess of the mouthpiece; and coupling a substance dispensing unit to the mouthpiece, wherein the substance dispensing unit is in communication with the sensing element and configured to dispense a substance to the intended user in response to the sensing element determining that the intended user&#39;s unique dentition is positioned within the recess.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation application of U.S. patentapplication Ser. No. 15/406,043, filed Jan. 13, 2017, now U.S. Pat. No.9,731,103, which is hereby incorporated by reference in its entirety.

TECHNICAL FIELD

The present disclosure relates generally to pharmaceutical oral doseadministration devices, and more particularly, to computerized oralprescription administration (COPA) devices and associated systems andmethods.

INTRODUCTION

The history of pharmacology has produced a continual evolution of routesof administration, pharmaceutical formulations, dosage forms, and dosingdevices in a continuing quest towards maximizing the effective benefitand relative costs of prescription medications. Administration ofprescribed substances may begin in controlled healthcare settings, forexample, at a healthcare facility or by a physician at a patient's home.Early-stage formulations may include liquid forms for parenteral (e.g.,into a blood stream) and enteral (e.g., into a gastro-intestine)administration including elixirs, tonics, solutions, suspensions, syrupsand eventually injections, intravenous (IVs), and epidurals. Theearly-stage formulations may be developed to produce advanced forms, forexample, via mechanization and formulation research. The early-stageformulations, the advanced forms, and further research and clinicalstudies such as patient acceptances of the early-stage formulationsand/or the advanced forms may contribute to the routes ofadministration, pharmaceutical formulations, dosage forms, and dosingdevices.

As the healthcare treatment transitioned from limited emergencyinvolvement into longer term chronic illness care, higher percentages ofthe prescribed medication administration shifts from the controlledhealthcare settings to patient managed settings. In a patient managedsetting, outside the control of a trained healthcare staff, theadministration of liquid formulations may be difficult due tonon-specific dosing instructions. Dosing based on teaspoon and/ortablespoon measurements may be vague and variable. Dosing cups may havedifferent measurement formats, and thus may cause confusion in a patientmanaged setting. In addition, dosing cups are often separated frominitial prescription bottles, and thus may lead to erroneousadministration.

The advancements of mechanical manufacturing systems and pharmacologyresearch enabled patient managed administrations of prescribedsubstances to shift from liquid formulations to pills (e.g., tablets orcapsule-formulations), which may have increased shelf life and allow forpatient ease of use, dosing exactness, and production cost reductions.Thus, a majority of oral medications in patient managed settings are nowpills. Additionally, there is an increased interest in microparticulateformulations including pellets, granules, micro particles, mini tablets,and the like. However, patients, such as infants, elderly, or impairedpatients, that cannot or prefer not to swallow tablets orcapsule-formulations may be given enteral oral liquid prescriptionsthrough dosing syringes in patient managed settings. In addition,parenteral liquid formulations are still commonly administered incontrolled healthcare settings since the parenteral liquid formulationsoften have the fastest rate of absorption and the most expedient successin the desired result and can improve localized administration,inventory control, fraud prevention, and administration path auditcapability.

Depending on the entity managing the administration of a drug, variousforms of the drug may be developed to meet expectations, needs, andchallenges of different entities. While there are some exceptions basedon effectiveness and toxicity, most pharmaceutical manufacturers mayproduce multiple formulations of drugs to support different routes ofadministration and dosing.

There is a growing demand for drug administration in patient controlledor managed settings as consumers increasingly engage in preventative orresultative treatment plans, which involve drug administration inpatient controlled settings. For example, outpatient surgeries and/orone-day inpatient surgery stays are increasingly common for significantmedical procedures, which may involve subsequent drug administrations ata patient's home. In addition, as the population ages, the demand forprescription management increases. Consumers may take multipleover-the-counter and/or prescribed medicines daily, where the medicinesare commonly in the form of pills. Unfortunately, the ease-of-use ofpills and the increasing number of consumers engaged in chronic patientmanaged treatment plans has led to misuse and mismanagement of many drugclasses.

For example, pill forms are lightweight, portable, recipientnon-specific, difficult for inventory management, don't carry individualidentification number, have extensive shelf life, and are inexpensive toproduce. Thus, the intakes or usages of pills are difficult to controlonce outside of healthcare managed environments. In addition, to achievethe economy of scale in the manufacturing process, pill production isscheduled based on maximizing the output of the machines, materials,and/or ingredients available instead of based on future demands. With afew exceptions, a minimal amount of the pills produced are wasted sincepills remain active for a long time. Pills proliferate our society andhave become conduits to addiction and abuse.

One such patient managed treatment that is highly susceptible toprescription misuse and mismanagement is opioid pain treatment. Forexample, according to the Food and Drug Administration (FDA),approximately 100 million people in the United States (US) suffer frompain in a given year. About 9 to 12 million of the pain sufferers havechronic or persistent pain, while the remaining pain sufferers haveshort-term pain from injuries, illnesses, or medical procedures. In2014, the Centers for Disease Control and Prevention reported that thenumber of annual opioid prescriptions in the US is about equal to thenumber of adults in the US population. While pain sufferers shouldbenefit from skillful and appropriate pain management, the misuse oraddiction of opioids needs to be controlled. FDA leaders and physiciansattempt to address the opioid epidemic by balancing two complementaryprinciples: deal aggressively with opioid misuse and addiction whileprotecting the well-being of people experiencing acute or chronic pains.However, the pain sufferers in areas where reforms, policies, andrestrictions aimed at opioid misuse have been implemented may notexperience the balance. Some states have implemented additional knownaddict or misuser databases that must be checked by providers prior toprescribing. However, physicians may not check the databases prior toprescribing due to the burden of using the systems and/or they may notwant to restrict access by true chronic pain sufferers. Other stateshave implemented reporting and audit trails to track physicians thathave prescribed from the opioid family. However, to avoid the additionalsteps and potentials for audit scrutiny, some physicians may refuse tooffer pain management or short-term pain prescriptions, and may referall cases to pain clinics.

Attempts at improved patient education, enhanced labeling, restrictiveprescribing, have led to higher costs for providers, patients,pharmacies, and insurance companies and less overall effectiveness forthe patients. In the end, true pain suffers struggle to have access toopioids while opioid misusers continue to manipulate the availableavenues for access regardless of the apparent oversights put in place.Policies and plans at various levels have not been successful and arenot sufficient to control or reduce the misuse of prescription drugs.Accordingly, improved devices, systems, and methods for drugadministration are needed.

SUMMARY

The following summarizes some aspects of the present disclosure toprovide a basic understanding of the discussed technology. This summaryis not an extensive overview of all contemplated features of thedisclosure, and is intended neither to identify key or critical elementsof all aspects of the disclosure nor to delineate the scope of any orall aspects of the disclosure. Its sole purpose is to present someconcepts of one or more aspects of the disclosure in summary form as aprelude to the more detailed description that is presented later.

The present disclosure provides computerized oral prescriptionadministration (COPA) devices and associated systems and methods. TheCOPA devices and associated systems and methods facilitate thecontrolled dispensing of medication to an intended user. In this regard,the identification of the intended user can be verified based on thedentition of the user before dispensing of the medication from thedevice. Further, the timing and/or volume of medication dispensed fromthe device can be controlled in accordance with dosage instructions forthe intended user. Parameters associated with the dispensing ofmedication (e.g., medication, dosage amount, timing, intended userinformation, etc.) can be tracked, stored in a COPA management system,and/or communicated throughout the healthcare continuum, includingmedical personnel, pharmaceutical personnel, patient, authorizedcaregivers, and/or insurers, such that patient's compliance with atreatment plan can be evaluated and/or the effectiveness of thetreatment plan can be evaluated. Additionally, the COPA managementsystem can send out alerts to participants of the healthcare continuumto serve as notices, reminders, and/or issues.

In one embodiment, a substance dispensing apparatus is provided. Theapparatus includes a mouthpiece having a recess sized and shaped to matewith an intended user's dentition; a sensing element coupled to themouthpiece and configured to determine whether the intended user'sdentition is positioned within the recess; and an actuator coupled tothe mouthpiece and in communication with the sensing element, theactuator configured to dispense a substance from a reservoir coupled tothe mouthpiece in response to the sensing element determining that theintended user's dentition is positioned within the recess.

In some embodiments, the sensing element is configured to determinewhether the intended user's dentition is positioned within the recess bycomparing position data of a user's dentition positioned within therecess to predetermined position data associated with the intendeduser's dentition. In some embodiments, the sensing element includes aposition sensor embedded within the mouthpiece. In some embodiments, thesensing element includes a plurality of positions sensors spacedembedded within the mouthpiece along the recess. In some embodiments,the sensing element is configured to determine whether the intendeduser's dentition is positioned within the recess by comparing pressuredata of a user's dentition positioned within the recess to predeterminedpressure data associated with the intended user's dentition. In someembodiments, the sensing element includes at least one pressure sensingelement embedded within the mouthpiece. In some embodiments, thepressure sensing element is configured to monitor pressure at aplurality of locations along the recess. In some embodiments, the recessis sized and shaped to mate with at least one of a lower row of teeth oran upper row of teeth of the intended user.

In some embodiments, the apparatus further comprises a processor incommunication with the sensing element and the actuator. In someembodiments, the apparatus further comprises memory in communicationwith the processor. In some embodiments, the memory includes dosageinstructions for the substance for the intended user. In someembodiments, the dosage instructions include at least a dosage amountand a dosage timing for dispensing the substance to the intended user.In some embodiments, the processor is configured to send an instructionto the actuator to dispense the substance from the reservoir inaccordance with the dosage instructions in response to the sensingelement determining that the intended user's dentition is positionedwithin the recess. In some embodiments, the processor is configured toinitiate alerts based on the dosage instructions. In some embodiments,the processor is configured to initiate the alerts by communicating witha communication device of the intended user. In some embodiments, theprocessor is configured to initiate the alerts based on a dosage timingof the dosage instructions. In some embodiments, the processor isconfigured to initiate the alerts by communicating with a communicationdevice of a medical provider. In some embodiments, the processor isconfigured to initiate the alerts based on a failure to dispense thesubstance in accordance with the dosage instructions. In someembodiments, the processor is configured to store dispensing dataassociated with the substance being dispensed from the reservoir in thememory. In some embodiments, the dispensing data includes a dispensedamount and/or a dispensed time.

In some embodiments, the substance includes a liquid. In someembodiments, the actuator includes a pump. In some embodiments, thereservoir includes a plurality of compartments, each of the plurality ofcompartments configured to contain a substance for dispensing to theintended user. In some embodiments, the actuator is configured todispense the substance from each of the plurality of compartments. Insome embodiments, the actuator includes a single actuator configured todispense the substance from each of the plurality of compartments. Insome embodiments, the actuator includes a plurality of actuators, whereeach actuator is configured to dispense the substance from acorresponding compartment.

In one embodiment, a method of dispensing a substance to an intendeduser is provided. The method includes determining whether an intendeduser's dentition is positioned within a recess of a mouthpiece, therecess sized and shaped to mate with the intended user's dentition; anddispensing a substance from a reservoir coupled to the mouthpiece inresponse to determining that the intended user's dentition is positionedwithin the recess of the mouthpiece.

In some embodiments, position data or pressure data is compared tocorresponding predetermined position or pressure data to determinewhether the intended user's dentition is positioned within the recessincludes. In some embodiments, the substance is dispensed in accordancewith dosage instructions for the intended user. In some embodiments, themethod further comprises storing dispensing data associated with thesubstance being dispensed from the reservoir. The dispensing data caninclude a dispensed amount and/or a dispensed time.

Additional aspects, features, and advantages of the present disclosurewill become apparent from the following detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

Illustrative embodiments of the present disclosure will be describedwith reference to the accompanying drawings, of which:

FIG. 1 is a top perspective view of a computerized oral prescriptionadministration (COPA) device according to embodiments of the presentdisclosure.

FIG. 2 is a bottom perspective view of a COPA device according toembodiments of the present disclosure.

FIG. 3 is a perspective view of a COPA device according to embodimentsof the present disclosure.

FIG. 4 is a perspective view of a COPA device positioned for docking ata docking station according to embodiments of the present disclosure.

FIG. 5 is a perspective view of a COPA device docked at a dockingstation according to embodiments of the present disclosure.

FIG. 6 is a perspective view of a COPA device and a pre-packagedmicro-pump unit positioned for coupling according to embodiments of thepresent disclosure.

FIG. 7 is a cross-sectional view of a COPA device according toembodiments of the present disclosure.

FIG. 8 is a schematic diagram of a micro-pump unit according toembodiments of the present disclosure.

FIG. 9 is a schematic diagram of a COPA system according to embodimentsof the present disclosure.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings, and specific language will be used todescribe the same. It is nevertheless understood that no limitation tothe scope of the disclosure is intended. Any alterations and furthermodifications to the described devices, systems, and methods, and anyfurther application of the principles of the present disclosure arefully contemplated and included within the present disclosure as wouldnormally occur to one skilled in the art to which the disclosurerelates.

Embodiments of the present disclosure provide mechanisms foradministering enteral oral medications through an ID-specific deviceregistered with a centralized management system. In an embodiment, thedevice comprises a mouthpiece including a recess sized and shaped tomate with an intended user's dentition. The mouthpiece may includeposition and/or pressure sensors positioned at various locations withinthe recess. The mouthpiece may include a micro-pump unit including aprocessor, a reservoir, an actuator, flow channels, and exit valves. Thereservoir may be filled with prescribed or over-the-counter medications.The processor may be in communication with the position and/or pressuresensors and the actuator. To administer the medications, the patient mayinsert the mouthpiece into the patient's mouth and close the mouth tobite on the mouthpiece. The position and/or pressure sensors may senseand measure the position of the user's dentition and associatedpressures from the bite. The processor may determine whether a match isfound between the measured positions and/or pressures and pre-recordeddata of the intended recipient patient. The processor may determinewhether the mouthpiece is positioned correctly. Upon detecting a matchand correct positioning, the processor may activate the actuator torelease an exact dosage of the medications through the flow channels andexit valves into the patient's mouth for ingestion. In an embodiment,the centralized management system may track the creation and preparationof the mouthpiece, the filling of the prescribed medications, and/or theadministration or dispensing of the prescribed medications throughvarious identification mechanisms.

The disclosed embodiments may provide several benefits. For example, theemployment of the unique individual mouthpiece with the embeddedprocessor and the centralized management system can ensure that theprescribed medications are delivered to the intended recipient. Thus,the disclosed embodiments may avoid misuse and mismanagement ofprescription medications. In addition, the disclosed embodiments mayallow healthcare providers and insurance companies to better track theadministering of the prescribed medications and evaluate the benefits,effects, and/or results of the prescribed medications more accurately.The disclosed embodiments may deliver a precise dosage of prescribedmedications to patients and may especially benefit patients that areelderly, impaired, or have behavioral issues that may limit theirabilities to self-administer prescribed medications. While the disclosedembodiments are described in the context of using dentition as a form ofverification for matching a prescription to an intended user, otherbiological markings (fingerprint, retina or iris scans, DNA, voicerecognition, etc.) may also be applied or used in conjunction withand/or in lieu of the dentition matching.

FIG. 1 is a top perspective view of a COPA device 100 according toembodiments of the present disclosure. The COPA device 100 may be usedfor delivering enteral oral liquid, multiparticulate, and/or other formsof drugs to an intended patient or user with controlled dosing. The COPAdevice 100 is a mouthpiece including a top side 102 and an oppositebottom side 104. The top side 102 includes a recess 110. The recess 110is sized and shaped to conform to an intended user's dentition. Forexample, the recess 110 includes an arrangement for receiving theintended user's upper teeth. The COPA device 100 may be constructed froma biocompatible impression material or polymer.

The recess 110 includes a plurality of sensors 112 positioned at variouslocations within the recess 110. In some embodiments, the sensors 112may be pressure sensors or optical position sensors. For example, thesensors 112 may be embedded at locations in contact with crevices,nooks, and gum lines of the user. When the user closes his or her moutharound the COPA device 100 using normal or force bite, the sensors 112can determine whether the user's dentition is positioned within therecess 110. In some embodiments, the sensors 112 may be housed on one ormore agile or flexible filament strands embedded within the recess 110.For example, each filament strand may be coupled between two and twentysensors 112 or any suitable number of sensors 112. In some embodiments,the sensors 112 may be formed and distributed on a meshed structureembedded within the recess 110. The meshed structure may include anysuitable number of sensors 112. The sensors 112 on the meshed structureor the filament strand may allow a pressure profile to be created whenthe user closes his or her mouth on the COPA device 100. In anembodiment, the sensors 112 may monitor and take position and/orpressure measurements when the user closes his or her mouth. Theposition and/or pressure measurements may be compared to pre-determineddata of the user's dentition as a form of verification to identify anintended recipient of a prescribed substance, as described in greaterdetail herein.

The COPA device 100 further includes a sealed prescription dispensingunit 120. The sealed prescription dispensing unit 120 may be positionedat the top center of the COPA device 100. The sealed prescriptiondispensing unit 120 may include a sealed sleeve 124 and a plurality ofaccess ports 122 extending from a top side of the sealed sleeve 124 intothe prescription dispensing unit 120. The access ports 122 may beconfigured to receive prescribed substances. For example, a clinician orpharmacy technician may fill prescribed substances into the prescriptiondispensing unit 120 via the access ports. The prescribed substances mayinclude formulations in various forms, such as liquid and/ormultiparticulate. The prescription dispensing unit 120 may include othercomponents, such as a processor, chambers, flow channels, actuators(e.g., micro-pumps), and exit valves, as described in greater detailherein.

The COPA device 100 may provide patient identification functionalitiesvia the patient's teeth imprint in the recess 110. For example, eachindividual has a unique dental imprint. While there are certain patternsfor the ages at which certain teeth may erupt, mature, and be replacedwith permanent teeth and for alignment of teeth types, the setting,size, angle, distance between certain points within a patient's mouth,and the resulting bite are different for different patients. Inaddition, damaged teeth, missing teeth, filled teeth, capped teeth, andprosthetics such as crowns, bridges, partial, and full dentures furtherthe identifying nature or uniqueness of the mouths of differentindividuals. Thus, the use of the COPA device 100 with the dentitionimprint can be effective in identifying a particular individual. TheCOPA device 100 may provide further patient identificationfunctionalities via various patient verification mechanisms implementedby a processor coupled to the mouthpiece (e.g., embedded within thesealed prescription dispensing unit 120), as described in greater detailherein.

The COPA device 100 further provides controlled prescriptionadministration functionalities via the sealed prescription dispensingunit 120. For example, the processor may be in communication with thesensors 112 and configured to determine whether the COPA device 100 iscorrectly positioned within the intended user's mouth. Upon detecting acorrect position, the processor may control the components within thesealed prescription dispensing unit 120 to release or deliver an exactdosage of the prescribed substances into the intended user's mouth, asdescribed in greater detail herein.

FIG. 2 is a bottom perspective view of the COPA device 100 according toembodiments of the present disclosure. The bottom side 104 includes arecess 210 sized and shaped to conform to an intended user's dentition,for example, the lower teeth. The recess 210 is embedded with aplurality of sensors 212 similar to the sensors 112. The sensors 212 maybe coupled to flexible or agile filament strands or a meshed structure.The prescription dispensing unit 120 includes a plurality of exit valves222 on the bottom side 104, where prescribed substances may be released.While the COPA device 100 is illustrated with a top recess 110 imprintedwith an intended user's upper teeth and a bottom recess 210 imprintedwith an intended user's lower teeth, the COPA device 100 can include asingle recess 110 or a single recess 210 to provide substantiallysimilar functionalities.

FIG. 3 is a perspective view of the COPA device 100 according toembodiments of the present disclosure. FIG. 3 illustrates the COPAdevice 100 with an upper portion of the sealed sleeve 124 (shown inFIG. 1) removed to provide a more detailed view of the prescriptiondispensing unit 120. As shown, the prescription dispensing unit 120includes a micro-pump unit 300. The access ports 122 may be incommunication with the micro-pump unit 300 to allow prescribedsubstances to be filled into the micro-pump unit 300.

FIG. 4 is a perspective view of the COPA device 100 positioned fordocking at a docking station 400 according to embodiments of the presentdisclosure. FIG. 5 is a perspective view of the COPA device 100 dockedat the docking station 400 according to embodiments of the presentdisclosure. The COPA device 100 may be positioned into the dockingstation 400 for storage, charging, and/or communicating over acommunications network. The docking station 400 may include a dockingcompartment 410, a wireless transceiver 420, a charging component 430, aplurality of indicators 440, and a COPA device sensing component 450.The wireless transceiver 420, the charging component 430, the indicators440, and the sensing component 450 may be arranged as shown or in anysuitable configuration on the docking station 400.

The docking compartment 410 may be sized and shaped to house the COPAdevice 100. The wireless transceiver 420 may be configured to transmitand receive data while the COPA device 100 is docked at the dockingstation 400 via a patient private wireless network, as described ingreater detail herein. The charging component 430 may include a hapticcharging component (e.g., for charging batteries) and may be configuredto charge the COPA device 100 while the COPA device 100 is docked at thedocking station 400. For example, the operations of the processor, theactuators, and the releasing of the prescribed substances operate basedon electrical power. The COPA device sensing component 450 may beconfigured to detect whether the COPA device 100 is docked correctly.For example, the bottom side 104 of the COPA device 100 may furtherinclude a docking station sensing component, where alignment between theCOPA device 100 and the docking station 400 may be detected via the COPAdevice sensing component 450 and the docking station sensing component.After detecting alignment, the charging component 430 may begin tocharge the COPA device 100. In addition, the COPA device 100 may uploadprescription administration activities via the wireless transceiver 420to a COPA management system, as described in greater detail herein. Theindicators 440 may include light-emitting diodes (LEDs). The indicators440 may be configured to indicate whether the COPA device 100 ispositioned correctly within the docking compartment 410 for charging andwireless communications. The indicators 440 may be further configured toindicate the charging status (e.g., power on/off) of the COPA device 100and/or the wireless transmission and/or reception activities of thewireless transceiver 420.

In some embodiments, the docking station 400 provides a closed loopcontrol system that can sense and detect the present of the COPA device100 at various stages of use and/or storage and provide correspondingfeedback and/or alerts to the user, caregiver, doctor, and/or pharmacy.For example, the indicators 440 may be configured to indicate that theCOPA device 100 is within proximity of the docking station 400, properlydocked within the docking station 400, improperly docked within thedocking station 400, charging, fully charged, transferring data,operating properly, operating improperly, and/or other statusindications. In some embodiments, the docking station 400 may include asound generation component (e.g., a speaker) that can generate varioustones and/or vibrations to indicate a current status, including theproximity or docking of the COPA device 100, charging activities, and/orcommunication activities. In some embodiments, the docking station 400can be in communication with a computing device such as a smartphone,tablet, or computer (e.g., via a wireless transceiver 420 or via a wiredconnection) and may send the feedback and/or alerts (as well as logs ofprescription administration activities obtained from the COPA device100) to a COPA smartphone or tablet application.

The COPA device 100 may be placed in the docking station 400 betweendosages for storage, charging and/or communication as needed (e.g.,multiple times per day, daily, nightly, weekly, etc.). The chargingand/or power needs of the COPA device 100, including the prescriptiondispensing unit 120, may be minimal since the operations associated withdispensing the medications may typically span short durations (e.g., 1minute or less). In addition to charging and wireless communications,the docking station 400 may help prevent the COPA device 100 from beinglost, misplaced, or damaged. For example, the docking station 400 mayfurther include locking mechanisms to provide additional protocols formatching the COPA device 100 to an intended user. In an embodiment, thedocking station 400 may include a thumbprint or optical scanningcomponent configured to unlock or release the COPA device 100 based on athumbprint verification against the intended user's thumbprint or anyother biological markings.

To prevent a successful matching and unlocking of the COPA device 100 byan unintended user for subsequent release of the prescription, theprocessor within the prescription dispensing unit 120 may be furtherconfigured to limit the activation time for the release of theprescription in conjunctions with the locking mechanisms. For example, acharged COPA device 100 may be inserted into a patient's mouth for drugdelivering or releasing at a designated time. When the administering ofthe medication is not time-specific, the controlling of the medicationrelease time may begin after an initial use. For example, the processormay be configured to record the time of the initial use and controlsubsequent releases based on an elapsed time duration or an intervalbetween prescribed dosages. The processor may be configured to releasethe drug at a designated time or designated time durations forsubsequent deliveries.

FIG. 6 is a perspective view of the COPA device 100 and the micro-pumpunit 300 positioned for coupling according to embodiments of the presentdisclosure. The micro-pump unit 300 is the core of the prescriptiondispensing unit 120. The micro-pump unit 300 includes a processor 310, areservoir 320, an actuator 330, and a plurality of exit valves 340. Theprocessor 310 is configured to control the micro-pump unit 300 andrecord activities associated with the COPA device 100, for example,dosage delivery time and amount, charged time, and/or wirelesscommunication activities. The reservoir 320 is configured to hold aprescribed substance, for example, as formulated for delivery via themicro-pump unit 300. The actuator 330 is configured to push or deliveran exact dosage of the prescribed substance upon activation. The exitvalves 340 are positioned at the bottom of the micro-pump unit 300 andare configured to release the prescribed substance for ingestion. Moredetailed views of the micro-pump unit 300 are shown in FIGS. 7 and 8 andthe interactions among the components of the micro-pump unit 300 aredescribed in greater detail below. The micro-pump unit 300 may bepre-packaged with a prescription through various mechanisms, asdescribed in greater detail herein. As shown, the COPA device 100 mayinclude a compartment 114 sized and shaped to receive the micro-pumpunit 300. For example, the pre-packaged micro-pump unit 300 may bepositioned within the compartment 114 and covered by the sealed sleeve124 (shown in FIG. 1) to form the sealed prescription dispensing unit120.

FIG. 7 provides a detailed view of the internal components of themicro-pump unit 300 and the interactions among the internal componentsaccording to embodiments of the present disclosure. In this regard, FIG.7 is a cross-sectional view of the COPA device 100 according toembodiments of the present disclosure. The cross-sectional view is takenalong the line 101 of FIG. 1. While FIG. 7 is illustrated with one ofthe sensors 112 positioned on a flexible or agile filament 116, thesensor 112 may be positioned on a meshed structure as described above.The micro-pump unit 300 is positioned within the compartment 114 (shownin FIG. 4) of the COPA device 100. The micro-pump unit 300 may furtherinclude a charging component 360 (e.g., batteries) and a memory 370(shown in FIG. 8). The charging component 360 may be in communicationwith the processor 310 and the actuator 330. When the COPA device 100 isdocked at the docking station 400 as shown in FIG. 4, the chargingcomponent 360 may be coupled to the charging component 430 of thedocking station 400 and configured to charge the COPA device 100 (e.g.,the processor 310 and the actuator 330) via battery charging or wirelesscharging. The memory 370 may include volatile memory and non-volatilememory of any suitable memory types, including random access memory(RAM), read-only memory (ROM), programmable read-only memory (PROM),erasable programmable read-only memory (EPROM), electrically erasableprogrammable read-only memory (EEPROM), dynamic random-access memory(DRAM), static random-access memory (SRAM), and combinations thereof.

The processor 310 can be in communication with the sensor 112, forexample, via a wire 710, and the actuator 330. The actuator 330 can bein communication with the reservoir 320 and the exit valves 340 via flowchannels 350. The reservoir 320 can be in communication with the accessports 122 (shown in FIG. 1) and the flow channels 350.

The reservoir 320 may include one or more chambers 322, for example,one, two, three, four, five, six, or any suitable number of chambers322. The chambers 322 may be configured to hold a prescribed substance720. In this regard, the number and size of the chambers 322 can beselected based on the number of prescribed substances, type(s) ofprescribed substances, and/or dosage amounts to be used. The chambers322 can be any size that will still allow the device to be positionedwithin the mouth of a patient. In some instances, the chambers 322 arein communication with corresponding chambers or channels formed in theCOPA device 100 to allow an increased volume of storage for theprescribed substance(s). The chambers 322 may be in communication withthe access ports 122. In some embodiments, each chamber 322 is incommunication with one of the access ports 122 through access cannulas730.

A clinician or a pharmacy technician may fill or refill the prescribedsubstance 720 via the access ports 122. The prescribed substance 720 mayinclude liquid formulations, powder formulations, multiparticulateformulations, or any other suitable formulations. In some embodiments,all chambers 322 are filled with liquid formulations. In some otherembodiments, one chamber 322 may be filled with a liquid formulation andanother chamber 322 may be filled with a powder or multiparticulateformulation. The prescribed substance 720 in the different chambers 322may be released at the same time to form a particular formulation or atdifferent times to prevent certain active ingredients in the prescribedsubstances 720 from reacting with each other. In this regard, eachchamber 322 may contain a different prescribed substance 720 for theintended user.

The actuator 330 may be a micro-pump suitable for delivery ofpharmaceutical formulations. The actuator 330 may be activated ortriggered by the processor 310 to cause the prescribed substances 720 toflow through the flow channels 350 and exit cannulas 740 and release viathe exit valves 340. The actuator 330 may be activated one or more timesto release an exact dosage of the prescribed substances 720. The flowchannels 350 may be constructed from suitable tubing materials. The exitvalves 340 may be any suitable flow control valves, for example, withelastomeric membranes, configured to prevent leakage of the prescribedsubstances 720 into the user's mouth or backflow of the prescribedsubstance from the user's mouth into the COPA device 100.

The processor 310 may be any suitable microcontroller or microprocessorconfigured to perform the functions described herein, includingfunctions such as performing patient identification and verification,performing position sensing and/or pressure detection (e.g., inconjunction with the sensors 112), instructing the actuator 330 torelease a dose of the prescribed substance 720, controlling the openingof the exit valves 340, controlling operation of components of themicro-pump unit 300 in accordance with dosage instructions for anintended user, storing dispensing data, etc. The dosage instructions mayinclude at least a dosage amount and timing for dispensing the substanceto the intended user. The dosage instructions may be stored in thememory 370.

In operation, the COPA device 100 may be inserted into the mouth of auser. The user may close his or her mouth around the COPA device 100 andbite into the COPA device 100, which may trigger the sensors 112 toperform position and/or pressure measurements. The processor 310 maydetermine whether the COPA device 100 is correctly positioned within theuser's mouth based on the measurements from the sensors 112. In someembodiments, position and/or pressure data of the user's mouth may berecorded and stored in the memory 370 when the COPA device 100 iscreated. The processor 310 may compare the current position and/orpressure measurements to the original position and/or pressure data todetermine whether there is a match between the current user of the COPAdevice 100 and the intended user of the COPA device 100. The processor310 may also compare the current position and/or pressure measurementsto the original position and/or pressure data to determine whether theCOPA device 100 is correctly positioned within the intended user'smouth.

When the user is verified as the intended user and the COPA device 100is correctly positioned within the intended user's mouth, the processor310 may send an activation instruction to the actuator 330 and open theexit valves 340 to administer one or more of the prescribed substances720 stored in the micro-pump unit 300 in accordance with dosageinstructions for the intended user. The activation of the actuator 330and the opening of the exit valves 340 may be based on dosageinstructions or prescriptions stored in the memory 370 when theprescribed substance 720 is filled.

In some embodiments, the COPA device 100 may include one or moreindicators that can provide feedback and/or alerts to the user when theCOPA device 100 is in use. The indicator(s) may include a vibratingcomponent, a sound generation component (e.g., speaker), and/or a visualindicator component. For example, the vibrating component can cause theCOPA device 100 to vibrate with different pulsing patterns to indicatethe different statuses of the COPA device (e.g., one vibration toindicate proper user authentication and initiation of dispensing, twovibrations to indicate completion of dispensing, patterned or repeatedvibrations to indicate an error with the COPA device, etc.). Similarly,the sound generation component can generate various tones and/orpatterns to indicate the different statuses of the COPA device.Likewise, the visual indicator component can include one or more LEDsthat display different colors and/or patterns to indicate the differentstatuses of the COPA device. The current status of the COPA device 100may be determined based on feedback from the processor 310, the sensors112 or 212 (e.g., correct or incorrect positioning of the COPA device100), sensors for monitoring the dispensing of the substance (e.g.,volume and/or flow sensors), the docking station 400, and/or othersensors or monitoring devices associated with the COPA device 100 and/orthe docking station 400 for determining the status of the COPA device100.

FIG. 8 is a schematic diagram of the micro-pump unit 300 according toembodiments of the present disclosure. FIG. 8 provides a more detailedview of the micro-pump unit 300 and interactions with the sensors 112and the docking station 400. As shown, the micro-pump unit 300 mayfurther include a wireless transceiver 380. The wireless transceiver 380may implement any suitable wireless communication protocols. Thewireless transceiver 380 may wirelessly communicate with the dockingstation 400, for example, to upload recorded activities or to downloadrevised or new dosage instructions, as described in greater detailherein. Further, the wireless transceiver 380 may wirelessly communicatewith other wireless communication devices, including a communicationdevice (e.g., computer, tablet, smartphone, etc.) of the intended user.In this regard, the processor of the micro-pump unit 300 can beconfigured to initiate alerts or reminders to the user (e.g., based on adosage timing of the dosage instructions) by triggering the intendeduser's communication device to issue such an alert or reminder (e.g., byactivating an audible and/or visual indicator). Similarly, the processorof the micro-pump unit 300 and/or the docking station 400 can beconfigured to initiate alerts or reminders through communications with acommunication device of a medical provider. For example, the micro-pumpunit 300 and/or the docking station may alert the medical provider basedon a failure to dispense the substance in accordance with the dosageinstructions (e.g., the patient is not taking the medication asprescribed) and/or multiple failed attempts to authenticate the intendeduser (e.g., indicating that someone other than the intended user isattempting to access the medication or that the intended user is havingdifficulties using the device).

FIG. 9 is a schematic diagram of a system 900 according to embodimentsof the present disclosure. The system 900 includes the COPA device 100,the docking station 400, a doctor 910, a pharmacy 920, apatient/authorized caregiver portal 930, and a central management system950 in communication with each other via a network 940. The network 940may include one or more wireless access networks and/or one or morewireline networks that may connect to a backbone network or theInternet. The network 940 may include network encryption and securitypolicies for protecting patients' privacy. The network 940 may includecloud storage for data storage and retrieval across the network 940based on the encryption and security policies. The doctor 910 may be aregistered doctor for the prescription management system. The pharmacy920 may be an approved pharmacy and/or a COPA device (e.g., themouthpiece) fabricator. A COPA fabricator may be individuals ororganizations trained in procuring standardized dental impressions(e.g., the COPA device 100) that capture varying individual elements ofthe intended recipients' dentition. The system 900 may provide anidentification system for tracking the path of prescriptionadministration and management to prevent misuse and mismanagement.

At a high level, the doctor 910 may prescribe a medication to a patientand the pharmacy 920 may create the mouthpiece for the patient and fillthe mouthpiece according to the prescription(s) provided by the doctor910. The pharmacy 920 may program the micro-pump unit of the mouthpieceto deliver an exact dosage of the prescribed medication and/or a dosageintake time. In this regard, dosage instructions for the patient may bestored in memory of the micro-pump unit. The patient may insert themouthpiece into the patient's mouth and the micro-pump unit will, uponverification that the user is the intended recipient, dispense theprescribed medication as programmed. The patient may dock the mouthpieceat the docking station when the mouthpiece is not in use. The dockingstation may charge the mouthpiece and/or communicate with the doctor 910and/or the pharmacy 920 via wireless and/or wired connections. Thedoctor 910 and/or the pharmacy 920 may monitor and retrieve informationassociated with the dispensing of the prescribed medication from thedocking station 400. The doctor 910 may provide instructions to adjustthe dosage instructions based on the monitoring and/or the retrievalinformation, and/or based on evaluations of the patient's progress. Thepharmacy 920 may send instructions to the docking station 400 to adjustthe dosage instructions stored in the memory of the micro-pump unitbased on the order from the doctor 910. For example, when the mouthpieceis docked at the docking station, the dosage instructions stored in thememory can be updated or re-programmed accordingly. Alternatively, thedosage instructions stored in the memory can be updated or re-programmedat the pharmacy 920. Similarly, the doctor 910 may prescribe newmedication based on the monitoring and/or the retrieval information,and/or based on evaluations of the patient's progress. The pharmacy 920may refill the micro-pump unit 300 accordingly.

The patient/authorized caregiver portal 930 may be stored on a computerserver or in cloud storage on the network 940. The management system 950may be hosted on the network 940. The management system 950 may includea master database that stores information associated with the patientand all COPA activities. For example, the management system 950 mayallow doctors (e.g., the doctor 910), assembly or fulfillmenttechnicians, pharmacists (e.g., the pharmacy 920), and any healthcarepersonnel that partake in the COPA process to access at least someportions of the master database, for example, based on logins. In anembodiment, different personnel may have different login profiles andthe accesses to the master database may be based on login profiles. Insome embodiments, the patient/authorized caregiver portal 930 may behosted on the management system 950 and may have certain accesses to themaster database. The patient information may include an identificationof the patient, health history, prescription history, identification ofthe processor 310 within the COPA device 100, identification of thedocking station 400 at which the COPA device 100 is charged, etc. Thepatient's identification may include a social security number (SSN) ofthe patient or other unique identifier. The prescription history mayinclude identifications of doctors (e.g., the doctor 910) who prescribedmedications to the patient, identifications of pharmacies (e.g., thepharmacy 920) at which the prescribed medications were filled orrefilled, identifications of the prescribed medications, and anidentification of the processor 310 within the micro-pump unit 300 wherethe medications were filled. The prescription history may also be storedand managed by the management system 950. The physicians'identifications may include national provider identifiers (NPIs) of thephysicians. The NPIS are unique identification number for HealthInsurance Portability and Accountability Act (HIPPA) covered physicians.The pharmacies' identifications may include an impression technicianidentifier (ID), an assembly technician ID, and a registered pharmacyID. The impression technician ID identifies the technician who createdthe COPA device 100 for the patient. The assembly technician IDidentifies the technician who assembled or filled the prescribedmedication into the micro-pump unit 300 of the COPA device 100. Thepharmacy ID identifies the pharmacy at which the prescribed medicationwas filled. The prescribed medications' identifications may includedosage IDs that identify each prescribed substance or formulation filledinto the micro-pump unit 300 of the COPA device 100.

In an embodiment, the doctor 910 may examine a patient and determinewhether alternative therapies may be helpful to the patient. When thedoctor 910 determines that the patient is in need of a particularmedication, for example, according to guidelines for drug formulationsbased on COPA dosing options, the doctor may order a prescription forthe patient. The doctor 910 may electronically transmit the prescriptionto the pharmacy 920 via the network 940, for example, according to HIPPAstandards of protection for data and electronic medical record (EMR)formats.

At a COPA fabricator, an impression technician may take an impression ofthe intended patient's mouth and teeth to create a mold for the COPAdevice 100, for example, according to COPA guidelines and instructions.The mold may include a sealed sleeve similar to the sealed sleeve 124.For example, the impression technician may use a dental tray filled withbio friendly polymers to create an imprint of the patient's dentition.COPA approved dentists, hygienists, and/or other trained professions(e.g., a COPA device assembly technician) may complete the creation ofthe mold for the COPA device 100.

An assembly technician may prepare a pre-packaged micro-pump unit 300.Each micro-pump unit 300 may be identified based on an ID of theprocessor 310 embedded within the micro-pump unit. The assemblytechnician may record the ID of the micro-pump unit 300 in themanagement system 950. For example, the assembly technician may enterthe ID into the management system 950, query a COPA device ID databaseof the management system 950 that stores and tracks IDs of COPA devices(e.g., the COPA device 100), and create a new record for the COPA device100 created for the patient. The assembly technician may activate theprocessor 310 within the micro-pump unit 300, for example, wirelessly.The activation may include programming the processor 310 according tothe order received from the doctor 910. The programming may include thedosage instructions for the patient (e.g., a dosage amount and thedosage timing for each prescribed medication). As described above,different chambers 322 may be filled with different formulations. Thus,the programming may include a release sequence, specific release times,and/or release durations for the different formulations, and/orintervals between releases. For example, some formulations may beprogrammed for instant release (IR) and some formulations may beprogrammed for extended release (ER).

After activating the micro-pump unit 300 or the processor 310, theassembly technician may place the activated micro-pump unit 300 into thetop center of the mold where the sealed sleeve is positioned. Themicro-pump unit 300 may be positioned such that the access cannulas 730extend outside the sealed sleeve through the access ports 122 and theexit cannulas 740 extend through the base of the mold. The assemblytechnician may place a filament or a mesh of sensors 112 into the recess110 of the COPA device 100. The assembly technician may attach a hosefrom an air compressor to the access ports 122 on top of the mold suchthat pressurized air may be pumped through the access cannulas 730 intothe micro-pump unit 300 to ensure that the flow channels 350 are notcompressed during the filling of the mold. The assembly technician maypump a liquid polymer into the mold and allow the liquid polymer to set.After the liquid polymer is set, the COPA device 100 is complete.

Upon completion of the COPA device 100, the COPA device 100 can betransferred to the pharmacy 920. At the pharmacy 920, a pharmacy staff(e.g., a COPA fulfillment technician) may place the COPA device 100 on apedestal or other structure configured to allow access to the micro-pumpunit 300 for filling. The pedestal may be covered by a sterile sleeveeach time prior to placing a COPA device on the pedestal. The pharmacystaff may retrieve a record of the COPA device 100 based on the ID ofthe processor 310 within the COPA device 100, for example, from the COPAmanagement system 950 via the network 940. The pharmacy staff mayprocure the medications (e.g., vials, pouches, bottles, etc.) from adrug manufacturer based on the dosage specified in the order receivedfrom the doctor 910. The pharmacy staff may update the record for theCOPA device 100. The pharmacy staff may activate or open control valvesat the access ports 122 to inject or deposit the formulated prescription(e.g., the prescribed substance 720) into one or more chambers 322 ofthe reservoir 320 via the access ports 122. After completing thefilling, the pharmacy staff may close the control valves. The pharmacystaff may repeat the same process for filling other chambers 322 in thereservoir 320. Subsequently, the releasing of the formulatedprescription is based on matching of the intended recipient's teeth andthe COPA device 100 as described above. It should be noted that in someembodiments, the pharmacy 920 and the COPA fabricator may be the sameentity.

The initial ID (e.g., of the processor 310) created for the COPA device100 can be a permanent ID for the COPA device 100. Informationassociated with the filled prescription may be associated with the ID ofthe COPA device 100 and recorded in the management system 950 and/or aninternal tracking system of the pharmacy 920. Thus, the COPA device 100is fully traceable through the creation and preparation path. Inaddition, the mold used to craft the COPA device 100 may be assignedwith a mold ID and may be stored in the management system 950 inassociation with the ID of the processor 310. Protocols for the use ofthe stored molds may be documented and records of subsequent mouthpiecesmay be stored in association in the management system 950. As such,misuse or fraud may be traced via the management system 950.

The pharmacy staff may pair the COPA device 100 with the docking station400. The pharmacy staff may record an ID of the docking station 400 inassociation with the COPA device 100 in the management system 950. Thewireless transceiver 420 of the docking station 400 may be recorded andregistered in the management system 950 for remote access to theprocessor 310 embedded in the COPA device 100. For example, a pharmacystaff may adjust the dosage of the filled prescribed medication based onthe instructions or an order of the prescribing doctor 910 by accessingthe processor 310 via the wireless transceiver 420 without the patientreturning the mouthpiece to the pharmacy 920 prior to depletion of theactive ingredient(s). The adjustment may allow for a limited number ofrevisions, for example, to the dosing amount per release, the timing ofthe release, suspension of one or more of the chambers 322.

The patient may pick up the COPA device 100 and the docking station 400from the pharmacy 920 and the pharmacy staff may provide instructions ofusage to the patient. The patient may insert the COPA device 100 intothe patient's mouth and close the mouth to bite on the COPA device 100so that the prescription dispensing unit 120 or the micro-pump unit 300may release the prescribed medication for ingestion. The patient mayclean the COPA device 100 and dock the COPA device 100 at the dockingstation 400 after use.

The patient and/or the authorized care giver may have access to anonline COPA account, for example, hosted on the management system 950via the network 940. The wireless transceiver 420 may detect andtransmit data such as activities recorded by the mouthpiece (e.g.,dispensing dosages and timings for each medication) to the managementsystem 950. The patient may view records of medications loaded into eachchamber 322 of the COPA device 100. The patient may view records of theadministration path of medications filled in the COPA device 100including the initial prescription and any subsequent revisions. Thepatient may view records of anticipated depletion timeline for thepatient to pick up a second pre-filled COPA device (e.g., the COPAdevice 100) and drop off the depleted COPA device if the treatment is arecurring treatment.

In an embodiment, the refill process for the COPA device 100 may usesimilar policies as today's drug refill policies. The COPA device 100may be used in prolonged treatment plans. A prescribing doctor 910 mayadjust and revise the prescription based on the treatment resultsobserved from the patient. The doctor 910 may electronically transferthe revised prescription to the pharmacy 920. The pharmacy staff or thefulfillment technician may send revised instructions to the processor310 wirelessly through the wireless transceiver 420 of the dockingstation 400. The management system 950 may house a full record of allrevisions. When the intended recipient has depleted the COPA as planned,or as revised, the COPA device 100 may be returned to the pharmacy 920for refills, for example, as directed by the prescribing doctor 910. Thepharmacy staff may flush saline solution into the COPA device 100through the access ports 122 into the sealed prescription dispensingunit 120 and out the exit valves 222. After flushing the COPA device100, the pharmacy staff may refill the COPA device 100 based on theorder received from the doctor 910 and may update the record in themanagement system 950. For example, if a prescription is written forthree refills, the record would indicate three dosage IDs in associationwith the ID of the processor 310 of the COPA device 100 and previousdosage IDs. By recording all information associated with the COPA device100, the patient and the dosage information in the management system 950may be retrieved at any time, including when the patient changesproviders or pharmacies during a treatment plan.

In an embodiment, when the COPA device 100 is no longer needed, forexample, at the end of a treatment plan or change of treatment plan, theCOPA device 100 may be deactivated and the management system 950 may beupdated to indicate the deactivation of the COPA device 100. In someembodiments, when deactivation time of the COPA device 100 is withincertain time limit, for example, X number of months, an assemblytechnician may reuse the original impression to build a new COPA device100. The ID of the processor 310 within the new COPA device 100 may bestored in the management system 950 in association with the old ID ofthe old COPA device 100. In an embodiment, when a COPA device 100 needsto be recast due to actual change in the dentition of a recipient, thecreation and preparation processes described above may be repeated.Information associated with the new mold may be stored on the managementsystem 950 in association with the patient and the prescribedmedications. By tracking all COPA devices 100 associated with aparticular patient or a particular prescription, it may be less likelyfor an unintended user to gain access to the prescribed medications orfor an intended user to provide false information for misuse ofprescribed substance.

The following table lists reference numerals and corresponding referencenames:

TABLE 1 Reference Numerals and Corresponding Reference Names. ReferenceNumerals Reference Names 100 COPA device 102 top side 104 bottom side110 recess 112 sensors 114 compartment 116 filament 120 prescriptiondispensing unit 122 access ports 124 sleeve 210 recess 212 sensors 222exit valves 300 micro - pump unit 310 processor 320 reservoir 322chambers 330 actuator 340 exit valves 350 flow channels 360 component370 memory 380 wireless transceiver 400 docking station 410 dockingcompartment 420 wireless transceiver 430 component 440 indicators 450COPA device sensing component 710 wire 720 prescribed substance 730access cannulas 740 exit cannulas 900 system 910 doctor 920 pharmacy 930patient/authorized caregiver portal 940 network 950 COPA managementsystem

Persons skilled in the art will recognize that the apparatus, systems,and methods described above can be modified in various ways.Accordingly, persons of ordinary skill in the art will appreciate thatthe embodiments encompassed by the present disclosure are not limited tothe particular exemplary embodiments described above. In that regard,although illustrative embodiments have been shown and described, a widerange of modification, change, and substitution is contemplated in theforegoing disclosure. It is understood that such variations may be madeto the foregoing without departing from the scope of the presentdisclosure. Accordingly, it is appropriate that the appended claims beconstrued broadly and in a manner consistent with the presentdisclosure.

What is claimed is:
 1. A method of assembling a substance dispensingdevice, the method comprising: forming a mouthpiece including a recesscustomized to match with an intended user's unique dentition; coupling asensing element to the recess of the mouthpiece, the sensing elementconfigured to determine if the intended user's unique dentition ispositioned within the recess of the mouthpiece; and coupling a substancedispensing unit to the mouthpiece, wherein the substance dispensing unitis in communication with the sensing element and configured to dispensea substance to the intended user in response to the sensing elementdetermining that the intended user's unique dentition is positionedwithin the recess.
 2. The method of claim 1, wherein the coupling thesensing element to the mouthpiece includes embedding the sensing elementwithin the mouthpiece.
 3. The method of claim 2, wherein the sensingelement includes at least one of a pressure sensor or a position sensor.4. The method of claim 1, wherein the sensing element includes one ormore sensors on a filament.
 5. The method of claim 1, wherein thesensing element includes one or more sensors on a mesh structure.
 6. Themethod of claim 1, wherein the forming the mouthpiece includes forming acompartment on the mouthpiece for housing the substance dispensing unit,and wherein the coupling the substance dispensing unit to the mouthpieceincludes engaging the substance dispensing unit with the compartment. 7.The method of claim 1, further comprising communicatively coupling thesubstance dispensing unit and the sensing element such that a processorof the substance dispensing unit is in communication with the sensingelement.
 8. The method of claim 1, further comprising: depositing asubstance into the substance dispensing unit; and configuring thesubstance dispensing unit to dispense a particular amount of thesubstance in response to the sensing element determining that theintended user's unique dentition is positioned within the recess basedon at least one of a dosage amount or a dosage timing.
 9. The method ofclaim 8, further comprising changing the particular amount of thesubstance to be dispensed based on at least one of an updated dosageamount or an updated dosage timing.
 10. The method of claim 9, furthercomprising receiving the updated dosage amount or the updated dosagetiming from a central management system.
 11. A method of managingsubstance administration, the method comprising: receiving, by asubstance management system, a dosage instruction for administering asubstance to an intended user through a mouthpiece including a recesscustomized to match with a unique dentition of the intended user;receiving, by the substance management system, activity informationassociated with administering the substance to the intended user; andgenerating, by the substance management system, a record based on thereceived activity information.
 12. The method of claim 11, wherein thedosage instruction includes at least one of a dosage amount or a dosagetiming, and wherein the activity information includes at least one of anadministered dosage amount or an administered dosage timing.
 13. Themethod of claim 11, further comprising receiving, by the substancemanagement system, identification information identifying themouthpiece.
 14. The method of claim 11, further comprising associating,by the substance management system, the record with at least one of anidentifier of the intended user, identification information associatedwith the mouthpiece, the dosage instruction, or the activityinformation.
 15. The method of claim 11, further comprising storing therecord in a network storage.
 16. The method of claim 15, furthercomprising: receiving, by the substance management system, a request forthe record; and retrieving, by the substance management system, therecord from the network storage in response to the request based on atleast a security policy.
 17. The method of claim 11, further comprisingsending, by the substance management system, an alert to at least one ofa communication device of the intended user or a communication device ofa medical provider based on a failure to dispense the substance inaccordance with the dosage instruction.
 18. The method of claim 11,further comprising sending, by the substance management system, an alertto at least one of a communication device of the intended user or acommunication device of a medical provider based on a dosage timing ofthe dosing instruction.
 19. The method of claim 11, further comprising:receiving, by the substance management system, a dosage updateinstruction for administering the substance; and sending, by thesubstance management system, a substance dispense adjustment to themouthpiece based on the dosage update instruction.
 20. The method ofclaim 11, wherein the activity information is received from a wirelesscommunication link in communication with the mouthpiece.